buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manu...
FDA Recall #D-0222-2024 — Class II — December 29, 2023
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Reason for Recall
Presence of Foreign Tablets/Capsules
Recalling Firm
Rising Pharma Holding, Inc. — East Brunswick, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
47,976 bottles
Distribution
Nationwide within the United States
Code Information
Lot #: BPA123098A, Exp. Date 06/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated